Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

Expanded access is currently available for this treatment.

Verified by APT Pharmaceuticals, Inc., February 2009

First Received: March 5, 2008 Last Updated: October 14, 2009 History of Changes

Sponsor:	APT Pharmaceuticals, Inc.
Information provided by:	APT Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00633373

Purpose

Currently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful improvement in survival and chronic rejection-free survival compared to placebo, but additional data supporting its use is needed prior to Food and Drug Administration (FDA) approval. This treatment use protocol is a mechanism for providing eligible lung transplant recipients early access to CIS in advance of FDA approval.

Condition	Intervention
Lung Transplant	Drug: Cyclosporine Inhalation Solution

Study Type:	Expanded Access
Official Title:	An Open-label Treatment Use Protocol of Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

Resource links provided by NLM:

MedlinePlus related topics: Lung Transplantation

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

Further study details as provided by APT Pharmaceuticals, Inc.:

Intervention Details:

Cyclosporine USP Inhalation Solution (CIS) 300mg/4.8 mL delivered via a disposable nebulizer. A titration phase of 10 days is recommended starting with 100 mg and then increasing over the 10 days to a maximum of 300 mg or the highest tolerated dose.

Eligibility

Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

Single-or double-lung transplant recipients.

Exclusion Criteria:

Known hypersensitivity to cyclosporine or propylene glycol (PG)
Females who are pregnant or are considering becoming pregnant
Females who are breast feeding a child.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633373

Contacts

Contact: Charles Johnson, MB, ChB	650-483-9531	charliej@aptbio.com
Contact: Wendy Verret, MPH	650-931-1666 ext 117	wverret@aptbio.com

Locations

United States, California
University of California at San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Florida Health Sciences Center
Gainesville, Florida, United States, 32610
Tampa General Hospital
Tampa, Florida, United States, 33601
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor Clinic, Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

APT Pharmaceuticals, Inc.

More Information

Publications:

Burkart GJ, Smaldone GC, Eldon MA, Venkataramanan R, Dauber J, Zeevi A, McCurry K, McKaveney TP, Corcoran TE, Griffith BP, Iacono AT. Lung deposition and pharmacokinetics of cyclosporine after aerosolization in lung transplant patients. Pharm Res. 2003 Feb;20(2):252-6.

Iacono AT, Smaldone GC, Keenan RJ, Diot P, Dauber JH, Zeevi A, Burckart GJ, Griffith BP. Dose-related reversal of acute lung rejection by aerosolized cyclosporine. Am J Respir Crit Care Med. 1997 May;155(5):1690-8.

Keenan RJ, Iacono A, Dauber JH, Zeevi A, Yousem SA, Ohori NP, Burckart GJ, Kawai A, Smaldone GC, Griffith BP. Treatment of refractory acute allograft rejection with aerosolized cyclosporine in lung transplant recipients. J Thorac Cardiovasc Surg. 1997 Feb;113(2):335-40; discussion 340-1.

Iacono A, Dauber J, Keenan R, Spichty K, Cai J, Grgurich W, Burckart G, Smaldone G, Pham S, Ohori NP, Yousem S, Williams P, Griffith B, Zeevi A. Interleukin 6 and interferon-gamma gene expression in lung transplant recipients with refractory acute cellular rejection: implications for monitoring and inhibition by treatment with aerosolized cyclosporine. Transplantation. 1997 Jul 27;64(2):263-9.

Iacono AT, Johnson BA, Grgurich WF, Youssef JG, Corcoran TE, Seiler DA, Dauber JH, Smaldone GC, Zeevi A, Yousem SA, Fung JJ, Burckart GJ, McCurry KR, Griffith BP. A randomized trial of inhaled cyclosporine in lung-transplant recipients. N Engl J Med. 2006 Jan 12;354(2):141-50.

Iacono AT, Corcoran TE, Griffith BP, Grgurich WF, Smith DA, Zeevi A, Smaldone GC, McCurry KR, Johnson BA, Dauber JH. Aerosol cyclosporin therapy in lung transplant recipients with bronchiolitis obliterans. Eur Respir J. 2004 Mar;23(3):384-90.

Iacono AT, Keenan RJ, Duncan SR, Smaldone GC, Dauber JH, Paradis IL, Ohori NP, Grgurich WF, Burckart GJ, Zeevi A, Delgado E, O'Riordan TG, Zendarsky MM, Yousem SA, Griffith BP. Aerosolized cyclosporine in lung recipients with refractory chronic rejection. Am J Respir Crit Care Med. 1996 Apr;153(4 Pt 1):1451-5.

Responsible Party:	APT Pharmaceutical Inc. ( Charles Johnson, MB. ChB. )
Study ID Numbers:	ACS004
Study First Received:	March 5, 2008
Last Updated:	October 14, 2009
ClinicalTrials.gov Identifier:	NCT00633373 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by APT Pharmaceuticals, Inc.:

lung
transplant
transplant rejection

Cyclosporine
bronchiolitis obliterans
aerosol

Additional relevant MeSH terms:

Anti-Infective Agents
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Cyclosporins

Immunosuppressive Agents
Pharmacologic Actions
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on November 27, 2009